Global Labeling Strategist

4 weeks ago


Uxbridge, United Kingdom Bristol Myers Squibb Full time

Job Summary

As a Global Labeling Strategist at Bristol Myers Squibb, you will play a critical role in shaping the company's labeling strategy for complex programs and high-priority assets. This is a unique opportunity to work closely with senior stakeholders, regulatory teams, and cross-functional contributors to drive efficient global label development and worldwide submissions and approvals.

Key Responsibilities

  • Provide oversight and guidance on labeling strategies that align with regulatory requirements globally.
  • Manage relationships with senior stakeholders and ensure that labeling claims across programs and therapeutic areas are consistent.
  • Lead key initiatives to support efficient global label development and worldwide submissions and approvals.
  • Drive labeling strategy in partnership with the Global Regulatory Team Leader, providing labeling expertise on CCDS, USPI, and SmPC.
  • Identify opportunities to influence regulatory policy and climate with respect to labeling content.
  • Coordinate labeling activities of multifunctional contributors, reviewers, and approvers, and manage the label review and approval process to maximize speed and quality.

Requirements

  • Masters of Life Sciences or equivalent, with a thorough understanding of scientific principles and at least 10 years of labeling and regulatory experience.
  • Proven understanding of the dynamics and purpose of the Company Core Data Sheets (CCDS) and the implications of the CCDS.
  • Proven ability to understand regulatory implications of product strategy related to labeling development, assessment, and management.
  • Experience in managing high to medium complex projects.
  • Ability to assimilate clinical and scientific information and present it in a concise manner.

What We Offer

Bristol Myers Squibb is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles. We care about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.



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